Cold chain: difference between revisions
Diff·revision 20 → 21·13:05, 8 Sep 2024
Difference between revision 20 and revision 21 of Cold chain. 5 lines changed; the page grew by 866 bytes.
| Revision 20 — 05:33, 1 Sep 2024 UnitsUrsula (talk) add PMID 8,537 bytes ±0 | Revision 21 — 13:05, 8 Sep 2024 PrepHPLC_Pia (talk) rv addition of price information per PP:VN 9,403 bytes +866 | ||
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| 52 | ; Time–temperature integrating indicators : Accumulate a colour change as a function of both temperature and time, approximating the cumulative thermal exposure that matters for degradation. | 52 | ; Time–temperature integrating indicators : Accumulate a colour change as a function of both temperature and time, approximating the cumulative thermal exposure that matters for degradation. |
| 53 | 53 | ||
| + | 54 | === Calibration and traceability === | |
| + | 55 | A temperature record is only as good as the calibration of the instrument that produced it. Compendial guidance on monitoring devices expects calibration traceable to a national metrology institute, at intervals appropriate to the device, and at points within the range of interest rather than only at ambient temperature. A logger calibrated at 25 °C and used at 5 °C may carry an error larger than its stated accuracy.{{r|usp1118}} | |
| + | 56 | ||
| + | 57 | The conventional expectation for a logger used in 2–8 °C distribution is an accuracy of ±0.5 °C across that range. This is an expectation drawn from qualification practice and from performance specifications for prequalified devices; it is not a requirement imposed by a general chapter, and articles asserting it as a standard have been corrected on this point.{{r|whotrs961,usp1118}} | |
| + | 58 | ||
| 54 | == References == | 59 | == References == |
| 55 | {{reflist}} | 60 | {{reflist}} |